TE Connectivity's Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.**About the position**:**Responsibilities**:- Oversee effective implementation of the Quality Management System throughout the company, including any business accreditations.- Maintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business.- Analyze current and future procedural needs of the business.- Organize and manage the plant internal audit system and the corrective action reporting system.- Conduct Quality System audits and assist in training/guidance to the auditors.- Support in hosting external Quality System audits.- Provide training on Quality issues and business processes.- Administer the regulatory training, CAPA, NC, Internal/External Audits System keeping Sr. Leadership informed of issues and progress on resolution.- Assist with training or quality awareness.- Prepare reports to communicate quality metrics.- Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.- Interact with teams on proposing and guiding appropriate Internal Audits and CAPA responses and resolutions.- Responsible to help, organize, prepare and present Quality Management Reviews.- In charge of CAPA Review Board coordination- Function as a resource for matters related to the Quality System.- Ensure a high level of internal and external customer service.- Follow all duties as assigned by the Quality Manager.**Education and Experience**:- Industrial / Production Engineer bachelor or similar degree.- Knowledge on 13485- Knowledge on CFR 820 CGMPs.- Certification from ASQ is a plus (CQE, CMQ, CSSBB).- At least 3-5 years of experience on medical industry and validation processes.- Language: Bilingual English / Spanish**Qualifications**:- Quality System, GMPs and QSR's knowledge.- Working knowledge of CAPA programs- Excellent communication and negotiation skills- Goal-oriented individual with strong leadership capabilities.- Able to interface with customers on technical issues- Able to work both independently and in a team-based environment- Excellent problem-solving skills- Ability to work in a diverse and dynamic environment- Planning and prioritizing activities- Ability to present data effectively- Understanding of cost and financial impacts- Knowledge of Microsoft Office Suite (word, excel, PowerPoint, MS project)**Competencies**:- Values: Integrity, Accountability, Teamwork, Innovation
